Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease

December 17, 2020 updated by: Novartis Pharmaceuticals

A Phase I, Multicenter, Open-label, Randomized Study Assessing the Pharmacokinetics, Safety, and Tolerability of Monthly Doses of Pasireotide i.m. LAR Injection in Patients With Acromegaly and Patients With Carcinoid Disease

This study will assess the pharmacokinetic profile and the safety/tolerability profile of single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with acromegaly and patients with carcinoid disease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
      • Liege, Belgium, 4000
        • Novartis Investigative Site
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5G1X5
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 12203
        • Novartis Investigative Site
      • Berlin, Germany, 10098
        • Novartis Investigative Site
      • Essen, Germany, 45122
        • Novartis Investigative Site
      • Leipzig, Germany, 04317
        • Novartis Investigative Site
      • Muenchen, Germany, 80336
        • Novartis Investigative Site
  • Netherlands
      • Rotterdam, Netherlands, 3015 CE
        • Novartis Investigative Site
  • Norway
      • Oslo, Norway, NO-0379
        • Novartis Investigative Site
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center SC - 4
      • Stanford, California, United States, 94304
        • Stanford University Medical Center Stanford Cancer Center (3)
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute Dept.of H.LeeMoffittCC&RI(1)
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria for patients with acromegaly:

  • Male or female patients between 18 and 80 years
  • Patients with acromegaly due to a pituitary adenoma with elevated GH and IGF-1 concentrations

Exclusion criteria for patients with acromegaly:

  • Patients with compression of the optic chiasm causing any visual field defect
  • Specific criteria apply for patients who have received certain types of therapies such as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to study start
  • Female patients who are pregnant or lactating

Inclusion criteria for patients with carcinoid disease:

  • Male or female patients aged ≥18 years
  • Patients with histologically confirmed, metastatic carcinoid tumors of the digestive system
  • Patients with elevation of chromogranin-A (CgA) and/or serotonin
  • Patients who are not adequately controlled by somatostatin analogues

Exclusion criteria for patients with carcinoid disease:

  • Specific criteria apply for patients who have received certain types of therapies such as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to study start
  • Female patients who are pregnant or lactating

Other protocol-defined in- and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOM230 LAR
Drug: Pasireotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection
Time Frame: Baseline, D7, D35, D63
in patients with acromegaly and in patients with carcinoid disease
Baseline, D7, D35, D63

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection
Time Frame: Baseline, D7, D35, D63
in patients with acromegaly and in patients with carcinoid disease.
Baseline, D7, D35, D63

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 9, 2007

First Submitted That Met QC Criteria

March 9, 2007

First Posted (Estimate)

March 12, 2007

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSOM230C2110
  • 2005-003348-75 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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